ES2885228T3 - Minimally invasive tissue treatment system - Google Patents

Abstract

A system comprising: a delivery device (12) adapted to deliver ultrasonic energy to pathological musculoskeletal tissue, the device including: a housing portion (20) defining a compartment and having an aspiration conduit (104) and a conduit irrigation (96); an ultrasonic transducer (22) disposed in the compartment of the housing portion (20) and adapted to translate a power signal into ultrasonic energy; a tip portion (24) coupled to the housing portion (20), the tip portion (24) adapted to deliver fluid arriving through the irrigation conduit (96) to a musculoskeletal tissue site and to deliver debris that coming from the musculoskeletal tissue site through the aspiration channel (104), including the tip portion (24): a cannula (90) having a proximal portion and a distal portion, the cannula (90) being coupled to the ultrasonic transducer (22) to receive ultrasonic energy from the ultrasonic transducer (22) and deliver the ultrasonic energy to the musculoskeletal tissue site; and a sleeve (92) adapted for percutaneous insertion and forming a lumen that receives the proximal portion of the cannula (90); and a controller (14) adapted to deliver the power signal to the ultrasonic transducer (22); characterized in that the delivery device (12) has been pre-set to deliver a frequency of ultrasonic energy from 25 kHz to 29 kHz to debride pathological musculoskeletal tissue.

Description

DESCRIPTION

System for minimally invasive tissue treatment

Background

Repetitive movement or the use of particular body tissues can lead to injury or the onset of painful conditions. For example, tennis elbow, or lateral epicondylalgia, is a clinical syndrome in which patients experience pain on the lateral side of the elbow. This lateral elbow pain can worsen over time, and despite proper treatment, many patients develop chronic symptoms and eventually become candidates for surgical treatment.

A number of surgical procedures have been described to treat chronic lateral epicondylalgia. Particular open techniques generally require open surgical dissection down to the pathologic tissue and thus necessitate repair of surgically compromised normal tissue. Some arthroscopic techniques may be somewhat less invasive, but these elbow arthroscopic techniques have been associated with neurological complications and may require the use of an expensive operating room and associated personnel. Various percutaneous techniques that release, excise, or resect pathologic tissue have been described. However, these percutaneous techniques generally require a significant skin incision, some surgical dissection, and the aforementioned use of an expensive operating room and equipment and support staff.

Patent document US 4,428,748 discloses a surgical system and apparatus that includes a handpiece with an ultrasonic motor to move a needle or other instrument with ultrasound and also includes a cutting tube or rotary motor that is mounted inside the needle. so that the tube can cut material passing through openings in the tube to be engaged by the tube.

"Piezoelectric surgery: Twenty years of use" (Labanca, M et al., British Journal of Oral and Maxillofacial Surgery, vol.

46, no. 4, pages 265-269) reports the advances in piezoelectric surgery over the previous 20 years and focuses on its use in different surgical areas.

WO 2009/105628 discloses systems, devices and methods for accessing and/or treating target body tissue (eg tendon tissue, ligament tissue, muscle tissue, bone tissue and the like) under the guidance of a team of ultrasound imaging.

US 5,897,524 discloses an ophthalmic surgery cassette configuration, the operative parts of which may be disposed of or re-sterilized, that is configured with an adapter mountable within the cassette receiving portal of a console using a peristaltic pump separate from the actuator and vent controls for mating with the lower end wall of a cassette.

Summary

The present invention provides a system according to claim 1. Preferred embodiments of the invention are illustrated in the dependent claims.

Brief description of the drawings

Figure 1 shows a system for accessing and treating tissue, according to some embodiments. Figure 2 is a longitudinal section of a delivery device of the system of Figure 1, according to some embodiments.

Figure 3 is an enlarged perspective view of a tip portion of the delivery device of Figure 1, according to some embodiments.

Figure 4 is a longitudinal section of the view of Figure 3, according to some embodiments.

Figure 5 is a schematic view of a controller of the system of Figure 1, according to some embodiments.

Figure 6 is a schematic view of a user interface of the controller of Figure 5, according to some embodiments.

Figures 7A, 7B, and 7C show a tube cassette of the controller of Figure 5, according to some embodiments.

Figure 8 shows a tenotomy procedure using the system of Figure 1 under ultrasonic guidance, according to some embodiments.

Although aspects of the invention are susceptible to various modifications and alternative forms, embodiments have been shown by way of example in the drawings and are described in detail below. However, it is not the intention to limit aspects of the invention to the particular embodiments shown and described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives that fall within the scope of the invention as defined in the appended claims.

Detailed description

Various embodiments described herein provide systems for accessing and treating targeted body tissue (eg, tendon tissue, ligament tissue, muscle tissue, bone tissue, and the like) under the guidance of a training team. ultrasound images. In accordance with the invention, the system includes a delivery device that is pre-set to a selected range of ultrasonic energy frequencies for debridement of pathological musculoskeletal tissue. According to some embodiments, the delivery device, also referred to as a handpiece, includes echogenic and/or etching material to facilitate ultrasonic imaging and is adapted for percutaneous insertion without producing a perceptible skin incision. Portions of the system, including the delivery device and associated tubing set, are optionally adapted to be disposed of after a single use.

In some applications, a high-frequency ultrasound transducer and associated ultrasound imaging equipment provide visual detail of the tendinopathic changes of lateral epicondylalgia, thus pathologic tissue is better identified at the time of a procedure without need to cut the skin. Thereafter, the pathologic or other target tissue is accessible and can be treated using the system without a perceptible skin incision. One procedure includes an ultrasound-guided percutaneous tenotomy for chronic lateral epicondylalgia, where the use of ultrasound equipment and echogenic instrumentation helps provide precise localization and treatment of pathologic tissue under real-time guidance while minimizing trauma to nontarget tissues. affected. Other tissues in the elbow joint and elsewhere in the body are contemplated for treatment using the systems described herein. Furthermore, in some embodiments, the systems additionally or alternatively serve to deliver therapeutic agents to the site before or after treating the tissue or are used to accomplish a variety of tissue treatments (eg, tissue disruption, debridement, decortication, or others). .

Figure 1 shows a system 10 for percutaneously accessing and acting on target tissue while helping to reduce collateral trauma, according to some embodiments. In some embodiments, the minimally invasive percutaneous nature of system 10 facilitates treatment of a patient in an office setting under local anesthesia. Treatment in an office setting is advantageous in several respects, including patient comfort and convenience and avoiding costs associated with operating room time and general anesthesia, for example. System 10 includes a delivery device 12 adapted to deliver ultrasonic energy to musculoskeletal tissue and a controller 14 connected to delivery device 12 (eg, via wired communication, wireless communication, or combinations thereof). Generally, various components of delivery device 12 contemplated for tissue contact are formed of biocompatible materials and/or other suitable materials depending on the application.

As shown in Figure 1, delivery device 12, also described as a handpiece, is optionally ergonomically designed, adapted to be held in the hand (eg, as a stylet), or otherwise adapted to be manually operated with one hand. In other applications, delivery device 12 is adapted to be handled automatically or semi-automatically (eg, as part of a robotic system). Figure 2 shows a longitudinal section of delivery device 12, according to some embodiments. As shown in Figure 2, delivery device 12 includes a housing portion 20, an ultrasound transducer 22 held within housing portion 20, and a tip portion 24 that is removably coupled to the tip portion. housing 20, according to some embodiments.

In some embodiments, the housing portion 20 provides means for holding the transducer 22 and forms an irrigation conduit 26 and a vacuum conduit 28, where the housing portion 20 includes a body 30 and an elongated mounting piece 32 received therein. body 30. As illustrated, portions of the irrigation and vacuum lines 26, 28 are formed by the body 30 and the elongated mounting piece 32. The body 30 defines an interior compartment 34 and extends from a proximal end 36 to a distal end 38, the body 30 forming a flap portion 40 towards the distal end 38, a grasping portion 42 proximal from the flap portion 40, and a separate fluid shunt 44 extending adjacent to the interior compartment 34. In some embodiments, body 30 is formed of acrylonitrile butadiene styrene, although a variety of materials are contemplated.

As shown, interior compartment 34 is generally an elongated space within body 30, extending through grip portion 42 distally through flap portion 40. In some embodiments, interior compartment 34 is adapted to receive the ultrasound transducer 22 and elongated mounting piece 32, as well as any other built-in components (for example, a power signal source such as a battery and control circuitry, or other features) and forms a part of the conduit. irrigation 26 in combination with the elongated mounting piece 32 as described below.

In some embodiments, the wing portion 40 has a generally narrower diameter relative to the grip portion 42. As shown, the wing portion 40 optionally includes an externally threaded portion 50 for releasably engage with the tip portion 24.

In some embodiments, grip portion 42 includes a contoured profile to enhance grip and facilitate manual control of device 12 by a user. As shown, fluid bypass 44 extends along an outer portion of grip portion 42 in accordance with some applications, where fluid bypass 44 defines a hollow lumen 54 having an inlet 56 from the interior compartment. 34 near proximal end 36 of body 30 and an outlet 58 back to interior compartment 34. As described below, fluid bypass 44 also forms a part of irrigation conduit 26.

In some embodiments, elongated mounting piece 32 includes a neck 64, collar 66, and stem 68 and defines an inner lumen 70 that forms a portion of vacuum conduit 28. Neck 64 is elongated and tubular and includes a portion internally threaded 72 within inner lumen 70. Collar 66 has a relatively larger diameter than neck 64 and is located between neck 64 and stem 68, where neck 64 extends distally from collar 66 and stem 68 extends proximally from collar 66. As shown, collar 66 optionally includes a gasket 74, or O-ring, to form a fluid seal with the interior compartment 34 of body 30 proximal to outlet 58 of the fluid bypass. 44. Stem 68 has a relatively smaller diameter than collar 66 and is adapted to coaxially receive ultrasound transducer 22 in accordance with some embodiments. To facilitate assembly, stem 68 is optionally formed of first and second tubular members 68A, 68B engaged by complementary threading and/or a friction fit, for example.

In some embodiments, the neck 64, collar 66, and first tubular member 68A of stem 68 are formed of a material that is suitable for transporting ultrasonic energy. For example, neck 64, collar 66, and first tubular member 68A are optionally formed of a stainless steel alloy, although a variety of materials are contemplated. In some embodiments, the second tubular member 68B of the stem 68A is formed of a cushioning or insulating material, such as a relatively soft polymeric material, to reduce or inhibit proximal or other undesirable ultrasonic energy transmission. For example, the second tubular member 68B is optionally formed of polytetrafluoroethylene, although a variety of materials are contemplated.

Ultrasonic transducer 22, or transducer 22, is held in interior compartment 34 of housing portion 20 by elongated mounting member 32 and provides means for generating ultrasonic energy from a power signal. Ultrasonic energy is optionally applied in a pulsed manner or in a continuous manner if desired. Transducer 22 optionally takes a variety of forms, but, according to some embodiments, includes an enclosure 80 that houses a plurality of piezoelectric crystals 82 and electrodes and a power conduit 84 for carrying a power signal to transducer 22. In particular, , transducer 22 is adapted to translate a power signal from controller 14 into ultrasonic energy. Enclosure 80 of transducer 22 is mounted to first tubular member 68A of stem 68 such that ultrasonic energy generated by transducer 22 is transmitted to and through elongated mounting member 32 distally to neck 64 of elongated mounting member. 32 Transducer 22 is optionally adapted to generate longitudinal vibration, transverse vibration, or combinations thereof at desired frequencies. For example, the number and configuration of piezoelectric crystals 82 are optionally varied to modify the ultrasonic frequency used for tissue treatment.

With transducer 22 secured coaxially around elongated mounting piece 32, inner lumen 70, and thus vacuum conduit 28, passes through transducer 22. As shown in Figure 2, vacuum conduit 28 is generally formed by the elongated mounting piece 32, where the inner lumen 70 of the elongated mounting piece 32 provides a suction conduit through the housing portion 20. To facilitate assembly of the system 10, the second tubular member 68B it is optionally secured to the proximal end 36 of the body 30 and is protected with a connector if desired. In some embodiments, the second singular element 68B is configured to include a removable filter and/or collection container for collecting and filtering debris from the target site.

As shown, irrigation conduit 26 is formed by a combination of body 30 and elongated mounting piece 32 of housing portion 20. In some embodiments, the assembly of housing portion 20 and elongated mounting piece 32 includes coaxially receiving elongated mounting member 32 within interior compartment 34 of body 30 such that gasket 74 couples body 30 proximal to outlet 58 of fluid shunt 44. Elongated mounting member 32 is optionally friction fit. , adhered, welded, or otherwise secured within the body 30 in accordance with various embodiments. Power conduit 84 of transducer 22 extends distally from enclosure 80, secured to proximal end 36 of body 30, and is optionally protected with a connector if desired.

The irrigation conduit 26 is defined by a first part 26A, a second part 26B, a third part 26C, and a fourth part 26D. The first part 26A optionally flows a tubular connector secured to the body 30 at the proximal end 36 and coupled to the inlet 56 of the fluid shunt 44. The second part 26B includes the fluid shunt 44. The third part 26C includes a portion of the inner compartment 34 between the neck 64 of the elongated mount piece 32 and body 30 that is distal to collar 66 of elongated mount piece 32 and proximal to wing portion 40 of body 30. Fourth portion 26D includes an interior compartment portion 34 between the wing portion 40 of the body 30 and the neck 64 of the elongate mounting piece 32. Therefore, the flow of fluid F passing the irrigation conduit 28 in a distal direction passes sequentially through the first, second, third, and the fourth parts, 26A, 26B, 26C, 26D, with fluid surrounding, or circumscribing, the neck 64 of the elongated mounting piece 32.

In some embodiments, tip portion 24 is adapted to engage housing portion 20 to deliver fluid arriving through irrigation conduit 26 to a target site, to deliver debris flow D from the target site into the target site. vacuum conduit 28, and to deliver ultrasonic energy from transducer 22 (carried by elongated mounting piece 32) to the target site. As described in greater detail below, in some embodiments, the tip portion 24 provides means for transmitting ultrasonic energy to a percutaneous musculoskeletal site at a preselected adjusted frequency to debride musculoskeletal tissue.

Figure 3 is an enlarged isometric view of the tip portion 24, with the body portion 22 of the device 12 being largely cut away in section, and Figure 4 is a longitudinal section of the view of Figure 3, in accordance with some realizations. As shown in Figure 3, tip portion 24 defines a distal section 24A adapted for percutaneous insertion without having to form a skin incision and a proximal section 24B adapted to engage housing portion 20.

As shown in FIG. 4, the tip portion 24 includes a cannula 90 and a sleeve 92 that covers a section of the cannula 90 to define a covered portion 90A and an exposed portion 90B of the cannula 90. The tip portion 24 it also defines an irrigation conduit 96 and a vacuum conduit 98. In some embodiments, the cannula 90 is generally a hollow tubular member having a distal insertion portion 100 and a proximal coupling portion 102. The cannula 90 also defines an inner lumen. 104 extending longitudinally through the insert and coupling portions 100, 102. In some embodiments, the cannula 90 is formed of a biocompatible, echogenic material for transporting ultrasonic energy. For example, cannula 90 is optionally formed of a stainless steel alloy in accordance with various embodiments. In other embodiments, the cannula 90 is covered or lined with echogenic material.

In some embodiments, the coupling portion 102 of the cannula 90 includes a threaded base 108 and a flange 110 extending distally from the threaded base 108. The threaded base 108 is adapted to mate with the internal threaded portion 72 of the elongated member. mount 32 with flange 110 abutting elongate mount member 32. Flange 110 has a relatively larger diameter than threaded base 108 and the diameter tapers to transition with insert portion 100. The insert portion 100 of the cannula 90 smoothly extends from the coupling portion 102 of the cannula 90 to a terminal end 114 and is adapted for percutaneous insertion.

In some embodiments, terminal end 114 of insert portion 100 is formed at an acute angle or in other embodiments it is simply square (not shown). In addition, insertion portion 100 optionally includes serrated edges or other surface features (not shown) to enhance ultrasonic debridement.

In some embodiments, the insertion portion 100 of the cannula 90 has a size of about 2.06 mm (12 gauge) or less, from about 2.06 mm (12 gauge) to about 1.45 mm (25 gauge) or from about 1.63mm (14 gauge) to about 0.64mm (22 gauge), for example. In some embodiments, the insertion portion 100 has a lateral width of about 2.5 mm or less, from about 2.2 mm to about 0.4 mm, or from about 2.1 mm to about 0.5 mm, for example. In some embodiments, the length of the insert portion 100 from about 76.2mm (3.0 inches) to about 6.35mm (0.25 inches), from about 68.58mm (2.7 inches) to about 0.5 inches (12.7 mm) or about 2.5 inches (63.5 mm) to about 1.0 inches (25.4 mm) for example. Although some examples that facilitate percutaneous insertion are provided herein, other dimensions are also contemplated.

As shown in Figure 4, sleeve 92 is a generally hollow tubular member adapted to extend over cover portion 90B of cannula 90. In some embodiments, sleeve 92 reduces unwanted collateral transmission of heat, ultrasonic energy, or other By-products of the ultrasonic energy that are transported along the covered portion 90B of the cannula 90 and also help provide a path for the irrigating fluid to the exposed portion 90A of the cannula 90. According to some embodiments, the sleeve 92 reduces or eliminates damage to non-target body tissues as a result of unwanted transmission of ultrasonic energy.

Similar to cannula 90, sleeve 92 has a proximal coupling portion 116 and a distal insertion portion 118 extending from coupling portion 116 and defining an inner lumen 120. Sleeve 92 or a portion thereof is optionally formed of a suitable biocompatible echogenic material to moisten products of ultrasonic energy (for example, heat and vibration). In other embodiments, sleeve 92 is lined with an echogenic material. In some applications, sleeve 92 is formed of a material that exhibits differential echogenicity from that of cannula 90. In such embodiments, both cannula 90 and sleeve 92 facilitate ultrasound imaging and separate identification during percutaneous insertion. . For example, in some embodiments, sleeve 92 is formed of an echogenic polytetrafluoroethylene, although other materials are contemplated.

As shown, mating portion 116 of sleeve 92 includes an internally threaded portion 126 adapted to mate with fin portion 40 of body 30 and tapers in diameter to transition with insert portion 118 of sleeve 92. coupling portion 116 also includes a gasket 128 or O-ring to form a fluid seal with fin portion 40. Insertion portion 118 of sleeve 92 extends smoothly from coupling portion 116 to a terminal end 130 and it is adapted for percutaneous insertion.

Terminal end 130 of insert portion 118 is optionally formed at an acute angle or, in other embodiments, is simply square (not shown). In some embodiments, the insertion portion 118 is adapted to leave the exposed portion 90B of the cannula 90 approximately 10 mm or less in length, eg, between 2 mm and approximately 10 mm, although a variety of dimensions are contemplated.

In some embodiments, and depending on the size of the cannula 90, as the sleeve 92 receives the cannula 90, the insertion portion 118 of the sleeve 92 has a size of approximately 12 gauge (2.06 mm) or less, approximately 2.06 mm (12 gauge) to about 0.455 mm (25 gauge), or from about 1.63 mm (14 gauge) to about 0.64 mm (22 gauge), for example. In some embodiments, the insertion portion 118 has a lateral width of about 2.5 mm or less, from about 2.2 mm to about 0.4 mm, or from about 2.1 mm to about 0.5 mm, for example. In some embodiments, the length of the insert portion 118 is from about 76.2mm (3.0 inches) to about 6.35mm (0.25 inches), from about 68.58mm (2.7 inches) to about 12.7 mm (0.5 inches) or from 63.5 mm (2.5 inches) to about 25.4 mm (1.0 inches) for example. Although some examples that facilitate percutaneous insertion are provided herein, other dimensions are also contemplated.

As shown in Figure 4, the vacuum conduit 98 is generally formed by the cannula 90, where the inner lumen 104 of the cannula 90 provides a suction conduit through the tip portion 24 with an inlet at the terminal end. 114 of cannula 90. Successively, irrigation conduit 96 is formed after securing cannula 90 and sleeve 92 together. In some embodiments, cannula 90 and sleeve 92 are separately secured to housing portion 20 of delivery device 12 and do not contact each other. Once the cannula 90 and sleeve 92 are secured together, with the cannula received in the inner lumen 120 of the sleeve 92, the cannula 90 and sleeve 92 define a gap therebetween to form the irrigation conduit 96 of the upper part. tip 24, with an inlet 96A to irrigation conduit 96 being defined between coupling portions 100, 116 of cannula 90 and sleeve 92, inlet 96A being positioned distal to joint 128. An outlet from the irrigation conduit 96B is defined between terminal end 130 of sleeve 92 and cannula 90. Thus, fluid F passing into irrigation conduit 96 in a distal direction passes from irrigation conduit 26 to inlet 96A and exits from outlet 96B with a noise that generally surrounds, or circumscribes, the insertion portion 100 of the cannula 90 and is directed toward the exposed portion 90B of the cannula 90.

In some embodiments, assembly of delivery device 12 includes removably securing tip portion 24 to housing portion by screwing tip portion 24 to housing portion 20 with mating portion 102 of cannula 90 engaging. close contact with the neck 64 of the elongated mounting piece 32 such that ultrasonic energy generated by the transducer 22 is transferred from the elongated mounting piece 32 to the cannula 90 and vacuum can be drawn through the vacuum lines 28, 98. In addition, gasket 74 on tip portion 24 seals sleeve 92 to wing portion 40 so that fluid can be delivered through irrigation lines 26, 96.

As mentioned above, in some embodiments, the insertion portions 100, 118 of the tip portion 24 help facilitate atraumatic penetration of skin and soft tissue - also described as percutaneous access without the need for a separate incision - under ultrasonic imaging. Also, in some embodiments, delivery device 12 is pre-set to a selected frequency or frequency ranges of ultrasonic energy. In accordance with the invention, an ultrasonic energy frequency range of 25 kHz to 29 kHz effectively debrides pathologic musculoskeletal tissue (eg, tendon-associated scar tissue) while reducing the likelihood of trauma to healthy soft tissue. . Various characteristics of the delivery device 12 influence the frequency of ultrasonic energy being delivered from the exposed portion 90B of the cannula 90, including the size, shape, and material of the elongated mounting piece 32, size, shape, and material of the cannula. 90, and the configuration of the transducer 22 (including size, shape, and number of piezoelectric crystals, for example).

Figure 5 is a schematic view of the controller 14, according to some embodiments. As shown, the controller 14 includes a housing 200; a command module 202 including a user interface 204, a power supply 206, and a processor 207; a vacuum source 208; an irrigation source 210; and a tube cassette 212.

Housing 200 is shown generally in Figure 1 and serves to house the various components and to provide connector ports, for example. Command module 202 is adapted to control the flow of vacuum source 208, control flow of irrigation source 210, turn on delivery device 12, and send and receive instructions to and from a user via user interface 204. , where processor 207 of command module 202 includes software and hardware (eg, ASIC or general purpose IC, memory, ports, etc.) to provide means for generating and managing a power signal to management device 12. In In some embodiments, command module 202 includes signal filter means 207A for delivering a conditioned power signal (eg, a sinusoidal power signal at a selected frequency and amplitude) to delivery device 12.

In some embodiments, user interface 204 includes a touch screen system and provides a means to control system 10 through a sequentially oriented operation process as will be described later. Power supply 206 optionally includes a battery, capacitor, transformer connected to an external power source, such as a wall outlet, combinations thereof, or other means for providing electrical power to system 10. As illustrated generally In some embodiments, power supply 206 directly or indirectly manages power to the various components of controller 14, as appropriate.

As shown, the vacuum source 208 is optionally a vacuum pump (eg, a peristaltic pump) disposed within the housing 200, although in other embodiments the vacuum source 208 is a connection to an external vacuum source (eg, a peristaltic pump). example, "household" vacuum), or other source to provide vacuum or suction flow D. Controller 14 also optionally includes a collection container 208A for receiving debris, fluid, or other material being sucked in by suction flow D. Irrigation source 210 includes a reservoir of irrigant material (eg, saline solution) that is pressurized by gravity, a plunger (eg, a syringe), or a pump (eg, a peristaltic pump driven by controller 14 and optionally arranged within housing 200) to generate fluid flow F. Controller 14 also optionally includes a valve actuator 214 to direct fluid flow F to vacuum lines. or 28, 98 of delivery device 12, for example for discharge purposes.

Figure 6 shows a screen of the user interface 204. In operation, the user interface 204 provides the user (not shown) with an intuitive sequence for operating the system 10 as will be described in greater detail below. As shown, the user interface 204 includes a prime phase 220, a purge phase 222, a reset phase 224, and allows for sequential operation of the delivery device 12 beginning with an ultrasound level selection 230, a selection of irrigation level 232, and a suction level selection 234, where a user is allowed to first select the ultrasound level 230, then the irrigation level 232, and then the suction level 234 in sequence when operating the system 10. In some embodiments, selections 230, 232, 234 illuminate sequentially, first with ultrasound level selection 230, and a user is not allowed to make a subsequent selection until that selection has been made . In some methods of operation, ultrasonic energy and irrigating material, or fluid flow, are generally delivered simultaneously, while aspiration flow is delivered intermittently. For example, ultrasound energy and irrigant flow optionally cease during aspiration and restart once treatment is restarted. Alternatively, the flow of irrigant material ceases and ultrasound energy continues during aspiration, although some of the beneficial effects of using irrigant material during ultrasonic treatment (for example, continued tip cooling and tissue emulsification, as well as other ) are potentially reduced by such an operation.

As indicated by the block arrow in Figure 5, tubing cassette 212 is removable from housing 200 and includes housing 296, valve 298, vacuum line 300, and irrigation line 302 (designated by dashed lines). ) held by housing 296, providing vacuum and irrigation lines 300, 302 connections between vacuum source 208 and delivery device 12 and between irrigation source 210 and delivery device 12. Vacuum line 300 also it is optionally connected to collection container 208A as mentioned above. In some embodiments, the vacuum and irrigation lines 300, 302 include a plurality of interconnected segments of medical tubing, although unitary constructions are also a potential option. Although collection container 208A is shown generally separate from cassette 212, in some embodiments collection container 208A is held by, formed as part of, or a component within cassette 212. In some embodiments, cassette 212 provides means for connecting vacuum line 300 to vacuum source 208 in a relatively sterile manner. For example, when vacuum source 208 includes a peristaltic pump, cassette 212 includes seating structure 296A for causing vacuum line 300 to couple to a pump driver 208B of vacuum source 208 that generates a flow of suction in the vacuum line 300.

Figure 7A shows an inner side of tube cassette 212 and Figure 7B shows a bottom side of tube cassette 212. tubes 212, according to some embodiments. Figure 7C is a schematic view of tube cassette 212, according to some embodiments. As described above, the tubing cassette 212 includes a housing 296, a seat structure 296A, a valve 298, a vacuum line 300, and an irrigation line 302 (vacuum and irrigation lines 300, 302 being optionally referred to as vacuum and irrigation lines). collectively set of tubes). In operation, pump driver 208B (FIG. 5) from vacuum source 208 (for example, a peristaltic pump) is received in seat frame 296A so that vacuum line 300 mates against seat frame 296A. between pump driver 208B and seat frame 296A. Valve 298 is engaged by valve actuator 214 to press valve 298 closed so that flow from irrigation line 302 will not travel through vacuum line 300 to delivery device 12 (designated generally by a dashed rectangle in Figure 7C). When vacuum line 300 is to be flushed, for example, valve 298 is released and fluid is able to flow through vacuum line 300 to the device and through vacuum lines 28, 98. As mentioned above , the irrigant material flowing through the irrigation line 302 is optionally pressurized by gravity or otherwise forced through the system 10.

Some examples of additional or alternative system features and applications, including reciprocating drive, working tip, and controller features, as well as various treatment methods, are provided in PCT International Publication No. WO 2009/105628, published on August 27, 2009, which has an international filing date of February 20, 2009, and is entitled "Systems, Devices and Methods for Accessing Body Tissue." For example, in some embodiments, the housing portion 20 of delivery device 12 includes or may be connected to one or more complementary working instruments (not shown), such as a trocar or percutaneous imaging head.

System assembly 10 includes remotely connecting delivery device 12 to controller 14, where controller 14 is a remote module, separate from delivery device 12. In other embodiments, delivery device 12 and controller 14, or parts of them, are formed as a single unit.

As indicated in Figures 1 and 5, a power line 304 is used to remotely connect the controller 14 to the power line 84 (Figure 2) of the transducer 22 so that the controller 14 can supply a power signal to the device. 14. Tubing cassette 212 is removably attached to housing 200 of controller 14 and vacuum line 300 is connected to vacuum line 28 (FIG. 2) and irrigation line 302 is connected to the source. irrigation 210 (FIG. 2). Next, a user (not shown) manipulates delivery device 12 under ultrasonic guidance and controls delivery of ultrasonic energy, fluid flow, and vacuum flow using interface 204 of controller 14, in accordance with some embodiment.

Figure 8 illustrates a method of delivering ultrasonic energy to a target musculoskeletal tissue site under ultrasonic imaging. As mentioned above, in some embodiments, the distal section 24A (FIG. 2) of the tip portion 24 is adapted to penetrate skin and soft tissue, thereby facilitating percutaneous access to the targeted musculoskeletal tissue site. .

As shown in FIG. 8, advancement of the distal section 24A of the tip portion 24 to a target musculoskeletal tissue site 400 is optionally performed under the guidance of an ultrasound imaging system 402 that includes an ultrasound transducer. high-frequency ultrasound 404 (eg, a frequency greater than about 10 MHz) and an imaging device 406. The imaging system 402, in combination with the echogenic nature of the tip portion 24, allows identification intraoperatively of the target tissue site 400 in need of treatment and the ability to deliver ultrasonic energy percutaneously from the exposed portion 90A of the cannula 90 to the target tissue site 400 .

Some methods of delivering ultrasonic energy to target tissue site 400 include connecting delivery device 12 to vacuum source 208, irrigation source 210, and power source 206 of controller 14 (directly or via command module). 202). Ultrasonic energy is generated by sending a power signal from command module 202 to ultrasound transducer 22. Ultrasonic energy is transmitted from ultrasound transducer 22 to cannula 90 such that exposed portion 90B of cannula 90 delivers ultrasonic energy at a frequency that is preselected to debride musculoskeletal tissue upon percutaneous insertion of the distal section 24A of the tip portion 24 to the targeted musculoskeletal tissue site 400 .

As mentioned above, a user optionally operates user interface 204 to sequentially initiate delivery device 12, including initiation of ultrasonic energy delivery, irrigation flow to device 12, and aspiration flow from device 12. Once tissue treatment is complete, according to some embodiments, tubing cassette 212 is removed from controller 14, discarded, and replaced with a second sterile tubing cassette (not shown) and previously connected or it is subsequently connected to a second sterile delivery device (not shown) to sterilize system 10 for a new procedure.

In some embodiments, a plurality of disposable delivery devices similar to delivery device 12 are provided with corresponding disposable cassettes, such as cassette 212 for each delivery device. Individual pre-setting of devices to an appropriate ultrasonic energy frequency, such as that described above, prior to administration to the user removes the need to test and adjust power signal parameters or delivery device settings. before or during each procedure. Instead, in some applications, a single-use administration device kit/cassette is installed or configured prior to administration to the end user, then used in a treatment procedure, and optionally discarded at the end of the procedure. , thereby reducing operation time, a level of skill required to "tune" system 10, and/or additional system components to tune delivery device 12. In addition, the combination of cassette 212 and delivery device 12 eliminates the need to sterilize equipment prior to a procedure, as all components that come into contact with body fluids are pre-sterilized and disposed of at the end of the procedure.

In accordance with various embodiments, system 10 is used in any of a variety of procedures. In some embodiments, system 10 is used to perform an ultrasound-guided percutaneous tenotomy. Some methods include the target tissue site 400 being pathological tissue (eg, a region of tendon-associated scar tissue 410), where the pathological tissue is identified using high-frequency ultrasonic imaging, the tip portion 24 is administered percutaneously, and in particular the distal section 24A, to the site

400 of target tissue under ultrasonic imaging, and ultrasonic energy is delivered through cannula 90 to debride musculoskeletal tissue (eg, scar tissue) that forms target tissue site 400 . Some methods include identifying the target tissue site 400 in its entirety at the time of a procedure without cutting the patient's skin. As described above, in some embodiments delivery device 12 is pre-set to deliver ultrasonic energy at a frequency that reduces the likelihood of trauma to healthy soft tissue while promoting debridement of pathological tissue. In addition, the percutaneous, minimally invasive nature of such a procedure makes it easy to access and treat such body tissue as part of an office procedure under local anesthesia.

According to some methods, after treating the target tissue and removing the distal section 24A of the tip portion 24 from the patient, the patient is discharged home after a brief period of office observation due to the nature of the injury. minimally invasive procedure (for example, as no local anesthesia would be required). For example, in similarly non-invasive procedures, post-procedure pain is generally variable, but often ranges from virtually no pain to moderately severe pain lasting less than 72 hours. Therefore, various embodiments of system 10 provide for an office procedure under local anesthesia, thereby resulting in cost savings to the patient by avoiding the cost of time in the operating room, where a patient may only need ice or ice. cooling packs for analgesia and edema control after treatment.

Although the present invention has been described with reference to various examples, those skilled in the art will recognize that changes in form and detail may be made without departing from the scope of the invention.

For example, various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the invention.

Claims (15)

1. A system comprising: a delivery device (12) adapted to deliver ultrasonic energy to pathological musculoskeletal tissue, the device including: a housing portion (20) defining a compartment and having an aspiration conduit (104) and an irrigation conduit (96); an ultrasonic transducer (22) disposed in the compartment of the housing portion (20) and adapted to translate a power signal into ultrasonic energy; a tip portion (24) coupled to the housing portion (20), the tip portion (24) adapted to deliver fluid arriving through the irrigation conduit (96) to a musculoskeletal tissue site and to deliver debris that come from the musculoskeletal tissue site through the aspiration channel (104), including the tip part (24): a cannula (90) having a proximal portion and a distal portion, the cannula (90) being coupled to the ultrasonic transducer (22) for receiving ultrasonic energy from the ultrasonic transducer (22) and delivering the ultrasonic energy to the musculoskeletal tissue site; Y a sleeve (92) adapted for percutaneous insertion and forming a lumen that receives the proximal portion of the cannula (90); Y a controller (14) adapted to deliver the power signal to the ultrasonic transducer (22); characterized in that the delivery device (12) has been pre-set to deliver a frequency of ultrasonic energy from 25 kHz to 29 kHz to debride pathological musculoskeletal tissue. 2. The system of claim 1, wherein the aspiration conduit (104) passes through the ultrasonic transducer (22). 3. The system of claim 1, wherein the lumen of the sleeve (92) and the cannula (90) define a fluid space that is in communication with the irrigation conduit (96) of the housing. 4. The system of claim 3, wherein the fluid space circumscribes the proximal portion of the cannula (90). 5. The system of claim 1, wherein the tip portion (24) is removably attached to the housing portion (20). The system of claim 1, wherein the tip portion (24) includes echogenic material such that the tip portion (24) is adapted for ultrasonic imaging. 7. The system of claim 1, wherein the sleeve (92) has a connector portion and an insert portion having an effective outside diameter that is less than the connector portion, the effective outside diameter of the insert portion being insert 0.914 mm (20 gauge) or less. The system of claim 3, wherein each of the cannula (90) and the housing portion (20) includes a proximal threaded portion for removably attaching the tip portion (24) to the housing portion ( twenty). The system of claim 1, wherein the cannula (90) defines an effective outside diameter of 0.914 mm (20 gauge) or less. 10. The system of claim 1, wherein the controller (14) includes a user interface adapted to guide a user of the system sequentially through an operating program. 11. The system of claim 1, wherein the controller (14) includes a vacuum pump and a vacuum port remotely coupled to the aspiration line (104) of the delivery device (12) and a fluid pump and a fluid port remotely coupled to the irrigation line (96) of the delivery device (12). 12. The system of claim 1, wherein the controller (14) is remotely connected to the delivery device (12) for delivering fluid flow and vacuum flow to the delivery device (12), the controller having ( 14) a main housing and a removable and disposable tubing cassette (212) removably secured to the housing (20) and adapted to be remotely connected to the aspiration line (104) and irrigation line (96) of the device administration (12). 13. The system of claim 1, wherein the controller (14) is held by the housing portion (20) of the delivery device (12). 14. The system of claim 1, wherein the delivery device (12) is adapted to deliver ultrasonic energy by means of at least one of basically longitudinal and basically transverse vibration of the cannula (90). 15. The system of claim 1, wherein the sleeve (92) has a connector portion and an insert portion having an effective outside diameter that is less than the connector portion, wherein the insert portion has a length 2.5 cm (1.0 inches) to 7.6 cm (3.0 inches), preferably 6.4 cm (2.5 inches) to 7.6 cm (3.0 inches).